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Stromedix, with Biogen Idec Roots, Seeks Exit from Regulatory Limbo

concern is,” Gilman says. “It’s a perfectly legitimate concern, it’s just that the way they want us to address it doesn’t really make sense.”

The company wants to start the mid-stage clinical trial in patients with the lung condition—which makes breathing difficult—by the end of this year, with the study involving kidney transplant patients to follow next year. Stromedix plans to conduct the clinical trials using tools that analyze the drug’s impact on fibrosis by measuring the expression of certain genes. For kidney fibrosis, the firm has identified 93 genes that its drug will target, Gilman says. Each of the genes expresses a protein that is likely to play a role in fibrosis or tissue injury. Many of the same genes are present in lung fibrosis. By measuring the activity of these genes, the company will have an indication of whether its drug is working.

The genetic biomarkers are a big help in the company’s pursuit of a lung fibrosis drug because there are believed to be multiple causes of ideopathic pulmonary fibrosis (IPF), and it’s been historically difficult to diagnose the disease. InterMune (NASDAQ:ITMN), the Brisbane, CA-based biotech, has long sought FDA approval for its treatment for IPF. Its drug, pirfenidone, is under FDA review after completing multiple pivotal trials, and it could become the first drug to be approved for the lung disease.

In its initial mid-stage trials, Gilman says, the firm might seek to test its drug in a relatively small number of patients for a relatively short period such as two to three months. That’s not long enough to show clinical improvements, he says, but it could be enough time to see signs of activity against fibrosis at the molecular level. And the genetic tests could provide such evidence. These data are also important to attract more investment dollars. The firm’s existing investors include Atlas Venture, Bessemer Venture Partners, Frazer Healthcare Ventures, and Red Abbey Venture Partners. Biogen also owns shares in the startup.

Indeed, Stromedix will likely need more support from its existing investors to advance its lead drug through mid-stage clinical testing. Of course, that was supposed to be covered by the company’s second-round financing, according to the original plans Gilman told Rebecca about back in April 2009. Again, few things go as planned in the biotech business.

“It’s a crazy, crazy business that we’re in,” Gilman says. “It attracts a certain type of person who can sort of get by on their own internal enthusiasm, because the external reinforcements are not really there very often.”